Debra Webster Email and Phone Number
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My breadth of experience as a pharmacology/toxicology reviewer at the United States Food and Drug Administration (FDA), a medical writer and regulatory consultant at Contract Research Organizations and in private practice, and creating and leading the regulatory affairs/medical writing group at a cell therapy biotech company have provided me with extensive experience in writing and reviewing regulatory submissions, leading regulatory interactions with the FDA, Health Canada, MHRA, and EMA, and providing regulatory strategy for drug and biologic product development projects for a broad range of therapeutic modalities and indications. I am an achiever who is results-oriented, sets high goals and is not deterred by challenges. By thinking strategically and being detailed oriented, looking for relevant patterns and identifying issues, I am able to pivot and propose alternative pathways when needed. I approach projects by obtaining input from all relevant stakeholders and incorporating that information into the appropriate strategy that can be effectively communicated to all levels of the organization. In leading programs, I strive to be adaptable, putting forth best-case scenarios while being forethoughtful in evaluating potential of worst-case scenarios for a given strategy. I am intellectually curious and enjoy learning collaboratively from other subject matter experts to fully understand a given program.
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Vice President Global Regulatory StrategySsi Strategy May 2024 - PresentParsippany, New Jersey, Us
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Vice President Regulatory AffairsAditum Bio Apr 2023 - May 2024Oakland, California, Us -
Vice President, Regulatory Affairs And Medical WritingBluerock Therapeutics May 2021 - 2023Cambridge, Massachusetts, Us -
Senior Director Regulatory AffairsBluerock Therapeutics May 2020 - May 2021Cambridge, Massachusetts, Us
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Director, Advanced Therapy Medicinal Product DevelopmentCardinal Health Dec 2018 - May 2020Dublin, Oh, UsRegulatory consultingProject lead for IND and NDA submissionSuccessful NDA approvalProject lead for FDA meetingsNonclinical support for INDs and NDAsBiotechnologyeCTDMedical and regulatory writing -
Principal Scientist, Regulatory Affairs And Product DevelopmentCardinal Health Regulatory Sciences Jan 2016 - Dec 2018-Develop and implement FDA global regulatory strategies, including the identification of gaps or risks, for products across a range of therapeutic areas.-Experienced in providing regulatory, nonclinical, and clinical strategy to support HCT/P based regenerative and advanced therapies, including CAR-T and gene therapies.-Prepare regulatory documents including meeting requests, meeting briefing documents, Request for Designation, and regulatory, clinical, and nonclinical sections of IND/NDA/BLA submissions. -Provide Advisory Committee Meeting support-Project leader for successful development of therapies from IND to marketing approval.-Project leader for FDA meetings with CDER, CBER, and Office of Combination Products"Views shared through LinkedIn status updates, long-form posts, recommendations provided, or in group discussions are my own and may not be representative of the views of my employer."
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Senior Associate, Clinical ResearchBeckloff Associates Dec 2010 - Jan 2013Medical writing, pre-clinical drug development.
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Senior Medical WriterQuintiles Oct 2007 - Dec 2010Durham, North Carolina, UsClinical ProtocolsClinical Study ReportsINDPMA -
Nonclinical And Regulatory ConsultantPrivate Practice 1992 - 2007IND reviewIntegrated summariesDue dilegence reviewRisk assessmentLiterature review
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Reviewing PharmacologistFda May 1987 - Jun 1992Silver Spring, Md, UsIND/NDA review
Debra Webster Skills
Debra Webster Education Details
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Virgina Commonwealth University/Medical College Of VirginiaPharmacology/Toxicology -
Virginia TechBiology
Frequently Asked Questions about Debra Webster
What company does Debra Webster work for?
Debra Webster works for Ssi Strategy
What is Debra Webster's role at the current company?
Debra Webster's current role is Vice President, Regulatory @ SSI Strategy | PhD Pharmacology/Toxicology.
What is Debra Webster's email address?
Debra Webster's email address is au****@****msn.com
What is Debra Webster's direct phone number?
Debra Webster's direct phone number is 1-913-269*****
What schools did Debra Webster attend?
Debra Webster attended Virgina Commonwealth University/medical College Of Virginia, Virginia Tech.
What are some of Debra Webster's interests?
Debra Webster has interest in Exercise, Home Improvement, Shooting, Reading, Gourmet Cooking, Sports, Food, Home Decoration, Health, Watching Sports.
What skills is Debra Webster known for?
Debra Webster has skills like Clinical Development, Regulatory Affairs, Medical Writing, Ind, Clinical Research, Pharmaceutical Industry, Glp, Fda, Gcp, Regulatory Submissions, U.s. Food And Drug Administration, Clinical Study Design.
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